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FDA 510(k)

CorPath 200 System

K-Number: K152999 · 2016-03-18

ApplicantCorindus, Inc.
Decision Date2016-03-18
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CorPath 200 System is a medical device manufactured by Corindus, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval number K152999. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorPath 200 System?

CorPath 200 System is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Corindus, Inc.. The 510(k) number is K152999.

When was CorPath 200 System approved by the FDA?

CorPath 200 System received FDA 510(k) clearance on 2016-03-18, under approval number K152999.

What company makes CorPath 200 System?

CorPath 200 System is manufactured by Corindus, Inc..

What is the FDA product code for CorPath 200 System?

The FDA product code for CorPath 200 System is DXX.

Other Devices by Corindus, Inc.

K160121CorPath GRX System K180517CorPath GRX System K173806CorPath GRX System K173288CorPath GRX System K202275CorPath GRX System K221464CorPath GRX System

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Related Devices (Code: DXX)

K160121CorPath GRX SystemCorindus, Inc. K180517CorPath GRX SystemCorindus, Inc. K173806CorPath GRX SystemCorindus, Inc. K173288CorPath GRX SystemCorindus, Inc. K202275CorPath GRX SystemCorindus, Inc. K221464CorPath GRX SystemCorindus, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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